The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration (PERFECT-FIT)

We aim to improve the yield and effectiveness of the Dutch colorectal cancer screening program by using a personalized screening strategy based on fecal Hemoglobin concentration in previous screening round for participants with a negative fecal immunochemical test (FIT).

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Personalized screening invitation interval

Detailed Description

A fecal Hemoglobin concentration just below the cut-off of the fecal immunochemical test (FIT) is associated with a higher risk for the detection of colorectal cancer of advanced adenomas at consecutive screenings. Individuals with these higher fecal Hemoglobin concentrations may benefit from shorter screenings interval, whereas individuals without any fecal Hemoglobin concentrations could benefit from longer screening intervals.

A randomized controlled trial will be conducted within the national CRC screening program among individuals with a negative FIT in the previous screening round. Individuals in the intervention arm will receive an invitation after 1, 2, or 3 years depending on their fecal Hemoglobin concentration in the previous round, whereas individuals in the control arm will receive an invitation after 2 years according to current practice.

The overall aim of this study is to improve the balance between harms and benefits of CRC screening, by using a personalized approach based on fecal Hemoglobin concentration at previous screening. More specifically, this study has three goals:

1. Evaluate the superiority of risk-based FIT screening in a randomized controlled study embedded in a running national screening program;
2. Evaluate the feasibility and acceptability of risk-based FIT screening in a national screening program;
3. Estimate the long-term effect of personalized screening versus uniform screening.

To achieve these goals a randomized controlled trial, focus groups and microsimulation modelling will be conducted.

• Study Type: Interventional
• Enrollment (Anticipated): 20000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esther Toes-Zoutendijk, PhD; Phone Number: +31107038454; Email: e.toes-zoutendijk@erasmusmc.nl
• Study Contact Backup: Name: Lucie de Jonge, MSc; Phone Number: +31107038591; Email: l.dejonge.3@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • ErasmusMC
    • Contact: Lucie de Jonge, MSc; Phone Number: +31107038591; Email: l.dejonge.3@erasmusmc.nl
    • Contact: Esther Toes-Zoutendijk, PhD; Phone Number: +31629535367; Email: e.toes-zoutendijk@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 54 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Previous negative FIT (below the cut-off of 47 microgram per gram feces)

Exclusion Criteria:

• Previously tested with FIT cut-off of 15 microgram per gram feces

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Participants receive a personalized screening invitation interval (1,2 or 3 years) based on their fecal Hemoglobin concentration of the negative fecal immunochemical test in previous round.	Other: Personalized screening invitation interval; Time to receive the next invitation for fecal immunochemical testing screening, will depend based on individuals risk determined by fecal Hemoglobin concentration
No Intervention: Control arm; Participants receive a standard screening invitation interval (2 years).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of colorectal cancer and advanced adenomas	Number of colorectal cancers and advanced adenomas per screened individual	6 months after the last invitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Number of individuals participating in personalized FIT screening	6 months after the last invitation

Collaborators and Investigators

• Sponsor: Esther Toes-Zoutendijk
• Investigators: Principal Investigator: Iris Lansdorp-Vogelaar, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: WO 19-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Outcomes of the study will be stored in the national screening information system, owned by a third-party sources. Data cannot be publicly shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No